Scientific Program 7
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Scientific Program
7
Day 1: Monday, May 19, 2014
Imre Klebovich
Co-Chair of the WorkshopCo-Chair of the Committee on Pharmaceutical SciencesChair of Working Committee on Separation Sciences of the
Hungarian Academy of Sciences (MTA) Budapest, Hungary
Ágoston Szél
Rector of Semmelweis University Budapest, Hungary
Sabine Kopp
World Health Organization (WHO) Geneva, Switzerland
Hilda Kőszegi-Szalai
GYEMSZI – National Institute of Pharmacy, Deputy Director General
Budapest, Hungary
Roger L. Williams
Former CEO and Chair, Council of ExpertsUnited States Pharmacopeial Convention (USP)
Rockville, MD, USA
Leslie Z. Benet
Founder President of the American Association ofPharmaceutical Scientists (AAPS)
San Francisco, CA, USA
Clive G. Wilson
Past President of the European Federation forPharmaceutical Sciences (EUFEPS)
Glasgow, Scotland, UK
Vinod P. Shah
Co-Chair of the WorkshopInternational Pharmaceutical Federation/SIG Chair of Regulatory Sciences (FIP)Former President of the American Association of
Pharmaceutical Scientists (AAPS) North Potomac, MD, USA
8
Opening Welcome9:00
Day 1: Monday, May 19, 2014
Regulatory Perspectives
Q and A
Session 1:
Panel Discussion I.
Regulatory Perspectives: Quality and BioequivalenceSession 2:
Stefan Mühlebach (Glattbrugg, Basel, Switzerland)Chairs:
Gordon L. Amidon (Ann Arbor, MI, USA) Moderators:
K. Wayne Riggs (Vancouver, BC, Canada)
Roger L. Williams (Rockville, MD, USA)
Tamás L. Paál (Szeged, Budapest, Hungary),Chairs:Romána Zelkó (Budapest, Hungary)
Hurdles and Challenges in Harmonising Drug Regulations
Basic Concepts: They Keep Changing
Coffee Break, Exhibition
Lunch, Exhibition
Tamás L. Paál
Leslie Z. Benet
University of Szeged, Szeged, Hungary
University of California, San Francisco, CA, USA
GYEMSZI-National Institute of Pharmacy, Budapest, Hungary
9:30
10:00
10:30
FDA Perspective on Product Quality and Bioequivalence
Vinod P. ShahInternational Pharmaceutical Federation / SIGChair of Regulatory Sciences, North Potomac, MD, USA
11:00
WHO Perspective on Quality Assurance and Medicinal Safety
Sabine KoppWorld Health Organization, WHO, Geneva, Switzerland
11:30
Newer Considerations and Regulatory Guidance on BE – EMA Perspective
Evangelos KotzagiorgisEuropean Medicines Agency, EMA, London, UK
12:00
12:30
13:00
9
Day 1: Monday, May 19, 2014
Q and APanel Discussion II.
Surendra K. Bansal (New York, NY, USA) Chairs:
László Endrényi (Toronto, ON, Canada) Chairs:
Sabine Kopp (Geneva, Switzerland) Moderators:
Meir Bialer (Jerusalem, Israel)
Peep Veski (Tartu, Estonia)
Vinod P. Shah (North Potomac, MD, USA)
Impact of Bioequivalence Studies on the Progresses of Pharma- ceutical Sciences in Generic Industry Within Last 35 Years
Advances in Pharmacokinetics Related EMA Regulations
Oral Drug Absorption: Science and Regulation
Drug Interactions - Alcohol, Smoking and Caffeine
Application of an In Vitro Lipolysis Model to Predict Positive Food Effect
Coffee Break, Exhibition
A. Atilla Hincal
José A. G. Morais
Panos Macheras
Imre Klebovich
James E. Polli
Hacettepe University, Ankara, Turkey İDE Pharmaceutical Registration Biopharmaceutics Consultation Education Ltd. Co., Ankara, Turkey
University of Lisbon, Lisbon, Portugal
National and Kapodistrian University of Athens, Athens, Greece
Semmelweis University, Budapest, Hungary
University of Maryland, Baltimore, MD, USA
10
14:00
14:30
15:00
15:30
16:00
16:30
17:00
Advances in Pharmacokinetics
Drug and Food Interactions
Session 3:
Session 4:
Day 1: Monday, May 19, 2014
Social Programs
Concert of the Semmelweis Chamber Orchestra
Banquet Dinner in the Hungarian National Gallery
in the Matthias Church, Conductor László Tardy
Royal Palace of Buda, Building C.
1014 Budapest, Szentháromság Square 2.
Entry by badge and invitation card only
1014 Budapest, Szent György Square 2.
Entry by badge and invitation card only
19:00
20:30
11
Welcome Addresses by:
Ferenc JoóPresident of Section of Chemical Sciences of the
Hungarian Academy of Sciences (MTA)
Éva SzökőPresident of the Hungarian Society for Pharmaceutical
Sciences (HSPS)
László VécseiPresident of the Section of Medical Sciences of the
Hungarian Academy of Sciences (MTA)
Vinod P. Shah and Imre KlebovichCo-Chairs of the Workshop
The performers of the evening:
Event Sponsor:
Botafogo Dance Ensemble
Jenő Esze's Dance and Salon Music Band
Day 2: Tuesday, May 20, 2014
Olavi Pelkonen (Oulu, Finland) Chairs:
Evangelos Kotzagiorgis (London, UK) Chairs:
István Tóth (Saint Lucia, Qld, Australia)
Constantin Mircioiu (Bucharest, Romania)
Role of Dissolution in Regulating Pharmaceutical Products
BCS and Beyond: Limitations and Harmonization (The New Science of BE)
Exploiting BDDCS and the Role of Transporters
Advances in IVIVC
Bioperformance Dissolution Standards: In Vivo Predictive Dissolution (IPD)
Coffee Break, Exhibition
Vinod P. Shah
Gordon L. Amidon
Leslie Z. Benet
James E. Polli
Gordon L. Amidon
International Pharmaceutical Federation / SIGChair of Regulatory Sciences, North Potomac, MD, USA
University of Michigan, Ann Arbor, MI, USA
University of California, San Francisco, CA, USA
University of Maryland, Baltimore, MD, USA
University of Michigan, Ann Arbor, MI, USA
12
9:00
9:30
10:00
10:30
11:00
11:30
BCS, Dissolution and Biowaiver
Advances in Dissolution
Session 5:
Session 6:
Day 2: Tuesday, May 20, 2014
Regulatory Trends in BioanalysisSession 7:
Hilda Kőszegi-Szalai (Budapest, Hungary)Chairs:, José A. G. Morais (Lisbon, Portugal)
Bioanalytical Method Validation and Samples Analysis – Lessons Learned from Regulatory Inspections
Where Are We with Respect to Global Harmonization in Guidance of Bioanalytical Method Validation?
Analytical Aspects of Biologics Applied in Pharmaceutical Development
Challenges in Using Capillary Electrophoresis in Analysing Therapeutic Proteins
Coffee Break, Exhibition
Surendra K. Bansal
Daniel Tang
Felix Heise, Hanns-Christian Mahler
Jim Thorn
F. Hoffmann-La Roche Inc., New York, NY, USA
ICON Development Solutions, APAC, Shanghai, China
F. Hoffmann-La Roche Ltd., Basel, Switzerland
AB SCIEX Separations Ltd., Warrington, UK
13:30
14:00
14:30
15:00
15:30
13
Q and APanel Discussion III.
Daan J. A. Crommelin (Utrecht, The Netherlands) Moderators:Clive G. Wilson (Glasgow, Scotland, UK)
Lunch, Exhibition 12:30
12:00
Day 2: Tuesday, May 20, 2014
Q and APanel Discussion IV.
István Greiner (Budapest, Hungary) Chairs:
Nicholas M. Fleischer (Washington, DC, USA) Moderators:
Milena Jadrijević-Mladar Takač (Zagreb, Croatia)
Sven Stegemann (Bornem, Belgium)
Biosimilars: Status Regulatory Pathways and Remaining Questions
Interchangeability: A Challenge for Non-Biological Complex Drugs (NBCDs)
Assessment of the Similarity and Interchangeability of Biological Drug Products
Daan J. A. Crommelin
Stefan Mühlebach
1 2László Endrényi , László Tóthfalusi
Utrecht University, Utrecht, The Netherlands
Vifor Pharma Ltd., Glattbrugg, SwitzerlandUniversity of Basel, Basel, Switzerland
1University of Toronto, Toronto, ON, Canada2Semmelweis University, Budapest, Hungary
14
17:00
16:30
16:00
17:30
19:30
Biosimilars and Complex Drug ProductsSession 8:
Social Programs
Concert of the Dohnányi Orchestra Budafok
in the Liszt Ferenc Academy of Music
Cocktail Reception in thestLiszt Ferenc Academy of Music, 1 floor
Conductor Gábor Hollerung
1061 Budapest, Liszt Ferenc Square 8.
Entry by badge and invitation card only
After the Concert:
The Sponsor of the Concert:
Day 3: Wednesday, May 21, 2014
Looking into the FutureSession 9:
Looking into the Future: New Trends?Session 10:
Imre G. Bajusz (Basel, Switzerland) Chairs:Irene Krämer (Mainz, Germany)
István Antal (Budapest, Hungary) Chairs:A. Atilla Hincal (Ankara, Turkey)
Reducing Regulatory Burden for Well-Established Drugs
Challenges of Biosimilars – A Perspective
New Challenges but Rewarding Opportunities in Translating Pharmaceutical Development Projects into Successful Therapeutics
The Me-Too Paradigm – a Threat for Pharmaceutical Progress? Roadmap Towards a New Quality Target Product Profile (QTPP) for Enhanced Therapeutic Entities
505(b)(2) New Drug Application Pathway vs. Abbreviated New Drug Application Pathway for Drug Approval in the US
Coffee Break, Exhibition
Roger L. Williams
István Greiner
Imre G. Bajusz
Sven Stegemann
Nicholas M. Fleischer
US Pharmacopeia, Rockville, MD, USA
Gedeon Richter Plc., Budapest, Hungary
Novartis Pharmaceuticals Ltd., Basel, Switzerland
Capsugel, Bornem, Belgium
The Weinberg Group Inc., Washington, DC, USA
9:00
9:30
10:30
10:00
11:00
11:30
Day 3: Wednesday, May 21, 2014
15
Modified Release Products: It's Time for International Harmonisation
Henning H. BlumeSocraTec R&D Ltd., Oberursel, Germany
12:00
Day 3: Wednesday, May 21, 2014
Q and APanel Discussion V.
Mitsuru Hashida (Kyoto, Japan) Chairs:
Leslie Z. Benet (San Francisco, CA, USA) Moderators:
Arto Urtti (Helsinki, Kuopio, Finland)
Panos Macheras (Athens, Greece)
Dosage Form Attributes and Biopharmaceutical Performance
Application of Cyclodextrins in Drug Formulations
Novel Approaches in Drug Delivery Systems
Coffee Break, Exhibition
Lunch, Exhibition
Clive G. Wilson
Lajos Szente
István Antal
University of Strathclyde, Glasgow, Scotland, UK
CycloLab Ltd., Budapest, Hungary
Semmelweis University, Budapest, Hungary
16
12:30
14:00
13:00
14:30
15:00
15:30
Looking into the Future: Biopharmaceutical AspectsSession 11:
Day 3: Wednesday, May 21, 2014
Advances in Targeted and Gene Delivery
Ocular Drug Delivery: Formulation and Bioequivalence Issues
Mitsuru Hashida
Arto Urtti
Kyoto University, Kyoto, Japan
Centre for Drug Research, University of Helsinki, Helsinki, FinlandSchool of Pharmacy, University of Eastern Finland, Kuopio, Finland
16:30
17:00
17:30
18:00
Day 3: Wednesday, May 21, 2014
17
Looking into the Future: New Delivery SystemsSession 12:
Daniel Tang (Shanghai, China) Chairs:Lajos Szente (Budapest, Hungary)
Pharmacovigilance Aspects of Biosimilar Products Irene Krämer
University of Johannes Gutenberg, Mainz, Germany
16:00
Q and APanel Discussion VI.
James E. Polli (Baltimore, MD, USA) Moderators:Henning H. Blume (Oberursel, Germany)
Closing Remarks
Vinod P. Shah and Imre Klebovich
Co-Chairs of the Workshop
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